Device Classification Name |
screw, fixation, bone |
||||
---|---|---|---|---|---|
510(k) Number | K021832 | ||||
Device Name | ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER | ||||
Original Applicant |
|
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Original Contact | sara b shultz | ||||
Regulation Number | 888.3040 | ||||
Classification Product Code |
|
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Date Received | 06/04/2002 | ||||
Decision Date | 06/26/2002 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Orthopedic |
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510k Review Panel |
Orthopedic |
||||
summary |
summary |
||||
Type | Special | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |